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Terminated

NCT Number: NCT01720186

Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer

This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Lung Nodule Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Claudius REGAUD

Toulouse, 31052, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
  • Either an extension assessment of non-small cell lung cancer;
  • Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
  • Patient who meets the following criteria to be eligible for an PET/CT imaging:
  • Patient able to maintain a supine position for 60 minutes
  • Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
  • Age ≥ 18 years
  • WHO ≤ 1
  • Well-informed written consent signed by the patient and collected before any specific procedure in the study
  • Patient member in a national insurance scheme

Exclusion criteria

  • Patient with a bronchial carcinoid or bronchoalveolar cancer
  • Patient with acute bronchopneumopathy
  • Not stabilized diabetic patient
  • Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
  • Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
  • Any usual formal indication against imaging examination PET/CT (important claustrophobia)
  • Patient unable to follow study procedures
  • Pregnant women or nursing mothers can not participate in the study
  • Men and women of childbearing age must use effective contraception at study entry and throughout the study
  • Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
  • Patient under legal guardianship

Treatment and study plan

PET/CT 4D imaging in a synchronized mode centered on the thorax.

Device

Primary outcomes

  1. Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )

    Time frame: 2 years

    feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):

    • Tolerance / acceptability of the patient to breathe into SPI throughout the examination)
    • Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100).
    • Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle).
    • Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"

Secondary outcomes

  1. Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)

    Time frame: 2 years

  2. Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm

    Time frame: 2 years

    dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle

  3. Measure of BTVrpm (= biologic tumoral volume)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: SPI COHERENCE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 2, 2012
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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